CT Dose Simulation Study for Appendicitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-03-31

Brief Summary

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The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute appendicitis, by using of dose simulation technique and iterative reconstruction.

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Detailed Description

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Three sequential non-inferiority tests are planned. First, three readers will review the original 2-mSv images. Second, the readers will review the 75%-dose images. After the readers review the 75%-dose images and before the readers reviewed the 50%-dose images, the non-inferiority of 75% dose to the original dose will be tested. If the non-inferiority is not accepted, the study will be terminated with the conclusion of 2 mSv as the lowest acceptable dose. If the non-inferiority is accepted, the study will be continue to the next step. In the same manner, the readers will review the next lower-dose images (50% and then 25%), and then the noninferiority will be tested against the original dose.

Conditions

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Appendicitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected appendicitis

Patients who are suspected as having acute appendicitis

CT

Intervention Type RADIATION

Contrast-enhanced CT images of the abdomen and pelvis will be obtained during the portal venous phase using a 256-channel CT system (Philips Healthcare, Cleveland, OH). The target median dose-length product (DLP) is 130 mGy·cm, which corresponded to an effective dose of 2 mSv with a conversion factor of 0.015 mSv·mGy-1·cm-1. The radiation output was automatically adjusted according to the individual patient's body size.

Interventions

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CT

Contrast-enhanced CT images of the abdomen and pelvis will be obtained during the portal venous phase using a 256-channel CT system (Philips Healthcare, Cleveland, OH). The target median dose-length product (DLP) is 130 mGy·cm, which corresponded to an effective dose of 2 mSv with a conversion factor of 0.015 mSv·mGy-1·cm-1. The radiation output was automatically adjusted according to the individual patient's body size.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 18-44 years of age.
* Emergency department visit with suspected symptoms and signs of acute appendicitis
* Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis